UK Office of Research Integrity

Menu

ORI Home Page

Click the year 2017 for current highlights:

For archived highlights, click on the year of your choice below:

[Note some links in these archived pages could be outdated. To ensure you have access to the most recent resource, visit ORI's current web pages.]

 

What's New? (2011)

This page offers news-worthy topics, helpful regulatory tips, and updates to IRB/ORI policy, procedures, and guidelines for IRB Members and others involved in human research in the year 2011. Note that due to the nature of web page evolution, some links may be broken. For the most current document links, search for the name of the document using the following search tool:

In order to receive electronic issues of the IRB Review Newsletter, or to receive a hard copy of past issues, contact the Office of Research Integrity at 859-323-2446 or e-mail Belinda.Smith@uky.edu and provide your name, e-mail address, department, campus address and phone number.

To jump to a month, click on your choice below:

 

 

Click here for free Acrobat Reader software, needed for opening PDF links.

 

December 2011

Back to Top

November 2011

  • 11/28/11: IRB Review Newsletter [PDF]
    • IRB Submission Tip: Collating Packets for IRB Reviewers
    • Holiday Announcement
    • ORI FAQ
    • IRB Form Updates and Clarifications
    • Upcoming Events

11/18/11 HOLIDAY ANNOUNCEMENT

The Office of Sponsored Projects Administration (257-9420), the Proposal Development Office (257-2861), the Office of Research Integrity–IRB & IACUC– (257-9428), and the Survey Research Center (257-4684) will be closed Monday, December 26 through Monday, January 2, and will reopen on Tuesday, January 3, 2012. If you anticipate a need for services provided by any of these offices during this time, please call the appropriate office(s) before December 16th.

Note to Human Research Investigators:

If you have received an IRB continuation review reminder, please be sure to check your approval end date and deliver materials to ORI as soon as possible to ensure IRB review and prevent lapse of approval.

The last medical IRB meeting in 2011 is December 20th  (submission deadline December 9th) and the last nonmedical IRB meeting is December 9th (submission deadline November 23rd) ].

Thanks and from all of us, we wish you a safe and happy holiday season!

Back to Top

October 2011

Back to Top

September 2011

  • 9/29/11: IRB Review Newsletter [PDF]
    • Submission Requirements to the IRB for DSMP and DSMB Activities
    • HHS Announces Proposed Comprehensive Changes to Human Research Regulations!
    • Updated Forms and Documents

Back to Top

August 2011

  • 8/30/11: Nonmedical IRB Meeting Date Change
    The deadline dates for submission of protocols to the Nonmedical IRB has been updated.  Please refer to the revised Nonmedical IRB full meeting schedule [PDF] for deadlines and meeting dates.  For additional information, please contact us at 859-257-1639.

  • 8/26/11: IRB Review Newsletter [PDF]
    • UK IRB Confidentiality and Data Security Guidelines for Electronic Data
    • Upcoming Events: Human Research Protection Regional Conference
    • Updated Investigational Drug and Device IRB Forms

Back to Top

July 2011

  • 7/21/11: REGISTRATION NOW OPEN

    UK Human Research Protection Regional Conference
    HUMAN SUBJECT PROTECTION: Don’t Stop Thinking About Tomorrow
    Thursday, September 15, 2011 9:00 am – 4:30 pm
    FULL BROCHURE (UK Faculty & Staff only): [PDF]
    Northern Kentucky Convention Center

Don’t miss the opportunity to hear national level speakers present on current issues and topics of interest to all members of the research community, including:

  • THE U.S. STD INOCULATION STUDIES IN GUATEMALA: DID THE U.S. HAVE TO APOLOGIZE?
  • INTERNET RESEARCH
  • U.S. HEALTHCARE REFORM AND HUMAN SUBJECT PROTECTION- OPPORTUNITIES AND CHALLENGE
  • WHAT’S THE POINT OF THE COMMON RULE?
  • ENGAGING AND RETAINING COMMUNITY AND MINORITY POPULATIONS IN CLINICAL RESEARCH: STRATEGIES AND OPPORTUNITIES
  • THE MIS-MEASURE OF IRBS

Attendance at the regional conference satisfies the U.K. human subject protection continuing education requirement.
Limited number of reduced cost “Early Bird” Registrations Available!
5+ Nursing CEU and CME credit hours.

Jointly Sponsored by:

  • UK Office of Research Integrity
  • Schulman Associates
  • IRB Cincinnati Children’s Hospital University of Cincinnati

Please contact us with any questions or to request a hard copy conference brochure by mail.

See upcoming events on our website @ http://www.research.uky.edu/ori/upcoming_events.htm.

Back to Top

June 2011

Back to Top

May 2011

  • 5/25/11: IRB Review Newsletter [PDF]
    • Guidance on Genome-Wide Association Studies (GWAS)l
    • Upcoming Events
    • ORI Guidance for Emergency Treatment Use of Investigational Drugs
    • New Addition to Online IRB Survival Handbook

April 2011

  • 4/27/11: IRB Review Newsletter [PDF]
    • Resources for Training “Non-Research” Personnel
    • Recruiting IRB Members

  • 4/15/11: Use of Investigational New Device "Form P"

    Information has been added to Form P, and the Form P Instructions web page to remind researchers that the IRB has standard operating procedures (SOPs) requiring periodic quality improvement reviews (QIR) for investigational device accountability. If your protocol is selected for a device accountability QIR, you should expect to be evaluated on site-specific policies and procedures for storage, control, dispensing, accountability, and monitoring of the device.

    To develop your own SOPs, you may use the Investigational Device Accountability SOP Template as a guide; available for downloading from the Office of Research Integrity Quality Improvement Program (QIP) web site (see QI Resources ). For an example of the areas evaluated during a device accountability QIR, see the Investigational Device Accountability Log under Sample Study Logs on the QIP web site.

Back to Top

March 2011

  • 3/21/11: IRB Review Newsletter [PDF]
    • FDA Final Rule on New Required Element for Informed Consent (21 CFR 50.27)
    • Nonmedical IRB News

February 2011

  • 2/28/11: IRB Review Newsletter [PDF]
    • Drug and Device Research
    • IRB Resource Guide Update
    • Nonmedical IRB Meeting Schedule Change

January 2011

  • 1/7/11: IRB Review Newsletter [PDF]
    • Responsible Conduct in Research (RCR) Resource Webpage
    • Navigating the IRB Process
    • Education Opportunity

  • 1/31/11: IRB RESOURCE GUIDE – UPDATED AND INTERACTIVE FOR 2011
    The IRB Resource Guide is a compendium of resources from which the ethical principles for conducting human research originate, along with significant federal regulations. The 2011 edition includes content revisions and web-link updates to federal agencies including the Food and Drug Administration and Office for Human Research Protection, both of which have recently revamped their websites.  Bookmark the guide online at:
    http://www.research.uky.edu/ori/human/guidance.htm#IRB_Resource
Back to Top